Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery: a Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Tidal volume
研究概览
简要总结
This study evaluates the efficacy and safety of a single session of positive expiratory pressure and of breath stacking technique in patients after cardiac surgery. The same patients will receive the two interventions, with an interval of 24 hours, and the acute effect of each will be verifed.
详细描述
Physiotherapy uses techniques and equipment that reduce postoperative pulmonary complications. The technique called breath stacking consists of an instrumental feature composed of a unidirectional valve coupled to a face mask to promote the accumulation of successive inspiratory volumes. The technique is used to prevent atelectasis and improve gas exchange. Another therapy is called expiratory positive airway pressure (EPAP) that uses positive end expiratory pressure (PEEP) in spontaneously breathing patients, keeping the airway open during expiration. The EPAP system consists of a face mask, a one-way valve and the expiratory resistor, which is responsible for resistance to expiratory flow, which will determine the level of PEEP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with indication for coronary artery bypass grafting and valve replacement, with surgical procedure for median sternotomy.
排除标准
- •incapacity to understand the Informed Consent Form.
- •cognitive dysfunction that prevents the performance of evaluations or interventions,
- •intolerance to the use of EPAP or BS mask
- •with chronic obstructive pulmonary disease (COPD)
- •cerebrovascular disease
- •chronic-degenerative musculoskeletal disease
- •chronic infectious disease
- •in treatment with steroids, hormones or cancer chemotherapy
- •hemodynamic complications (arrhythmia, myocardial infarction during the operation, with blood loss ≥ 20% of the total blood volume, defined by Mannuci, et al., 2007)
- •mean arterial pressure <70 mmHg and reduced cardiac output, requiring the use of intra aortic balloon or vasoactive drugs
- •tracheal intubation for more than 12 hours after admission to the ICU or reintubated
- •individuals unable to maintain airway permeability.
结局指标
主要结局
Tidal volume
时间窗: 12 to 24 hours after removal of drains and 24 hours after primary intervention
It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period. This measurement will be obtained through the the division of the minute volume by the respiratory rate.
Forced vital capacity (FVC)
时间窗: 12 to 24 hours after removal of drains and 24 hours after primary intervention
It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period, as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability \<5%) and considered the best curve for the study.
次要结局
- Forced expiratory volume in the first second (FEV1)(12 to 24 hours after removal of drains and 24 hours after primary intervention)
- Peak expiratory flow (PEF)(12 to 24 hours after removal of drains and 24 hours after primary intervention)
- Forced expiratory flow between 25 and 75% of the curve of FVC (FEF25-75)(12 to 24 hours after removal of drains and 24 hours after primary intervention)
- Minute volume(12 to 24 hours after removal of drains and 24 hours after primary intervention)
- Respiratory rate(12 to 24 hours after removal of drains and 24 hours after primary intervention)
- Heart rate(12 to 24 hours after removal of drains and 24 hours after primary intervention)
- Peripheral Oxygen Saturation (SpO2)(12 to 24 hours after removal of drains and 24 hours after primary intervention)
- Blood pressure(12 to 24 hours after removal of drains and 24 hours after primary intervention)
- Heart work measurement(12 to 24 hours after removal of drains and 24 hours after primary intervention)
- Thoracoabdominal mobility(12 to 24 hours after removal of drains and 24 hours after primary intervention)
- Painful perception in the surgical incision(12 to 24 hours after removal of drains and 24 hours after primary intervention)
- Degree of dyspnea(12 to 24 hours after removal of drains and 24 hours after primary intervention)
- Signs of respiratory discomfort (dizziness, tachypnea, sweating, use accessory musculature)(12 to 24 hours after removal of drains and 24 hours after primary intervention)
研究者
Prof. Dr. Antônio Marcos Vargas da Silva
Principal Investigator
Universidade Federal de Santa Maria